IPI-145 ADME and Absolute Bioavailability Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IPI-145

• Registration Number: NCT01836861
• Lead Sponsor: SecuraBio

Brief Summary

This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

Detailed Description

In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.

In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.

There will be a washout period of at least 14 days between Period 1 and Period 2.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-04
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Study Completion: 2013-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
• In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
• Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria

• Evidence of clinically significant medical conditions
• History of gastrointestinal surgery that may affect drug absorption
• Positive or indeterminate QuantiFERON-TB Gold test at screening
• Any active infection at the time of screening or admission
• Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening
• Irregular defecation pattern (less than once per 2 days)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPI-145 and [14C] IPI-145	IPI-145	-

Primary Outcome Measures

Name	Time	Method
PK parameters (AUC) and radioactivity excreted in urine and feces	over 144 hours
PK parameters (t1/2) and radioactivity excreted in urine and feces	over 144 hours
PK parameters (AUC) of IPI-145 in plasma	over 48 hours
PK parameters (Cmax) of IPI-145 in plasma	over 48 hours
PK parameters (t1/2) of IPI-145 in plasma	over 48 hours
PK parameters (Cmax) and radioactivity excreted in urine and feces	over 144 hours

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events following a single dose administration of IPI-145	over 4 weeks

Trial Locations

Locations (1)

Pharmaceuticals Research Association (PRA); 🇳🇱 Zuidlaren, Netherlands